NAFRINSE PACKETS VERY BERRY

NAFRINSE PACKETS VERY BERRY- sodium fluoride powder
Young Dental Manufacturing Co 1, LLC.

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Inactives

Saccharin Sodium, Potassium Sorbate, Citric Acid, Flavoring

Dye ( Only present in Mint and Very Berry flavors)

Warning:

This Packet contains sodium fluoride powder, contents poisonous if swallowed. keep away from children. Store in a dry place at controlled room temperature. For professional use only.

DO NOT SWALLOW

MISSUSE If child swallows dispensed amount of mouth rinse in a cup:

1. Do not panic -this amount should not hurt the child

2. In rare cases the child may feel slightly nauseous.

The child may have a serving of milk or ice cream to relieve the nausea. EMERGENCY TREATMENT If a child swallows more than one dispensed amount in a cup or powder contents of the fluoride mouth rinse packet call the Poison Control Center at 800-222-1222

Directions

Mix contents with stated amount of tap water until dissolved (read directions on jug label) Makes an 0.2 % solution of sodium fluoride mouthrinse aftert dilution. Swish 10 ml (2 teaspoons) around vigorously in the mouth for one minute and then spit out. To be used once a week.

NAFRINSE PACKETS VERY BERRY sodium fluoride powder

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0273-8016 Route of Administration DENTAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Sodium Fluoride (Fluoride Ion) Fluoride Ion 1 g in 1 g

Inactive Ingredients Ingredient Name Strength SACCHARIN SODIUM Potassium Sorbate ANHYDROUS CITRIC ACID

Product Characteristics Color Score Shape Size Flavor BERRY (very berry) Imprint Code Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:0273-8016-03 50 PACKET in 1 PACKAGE contains a PACKET 1 3 g in 1 PACKET This package is contained within the PACKAGE (0273-8016-03)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 09/21/2017

Labeler — Young Dental Manufacturing Co 1, LLC. (006309355)

Registrant — Young Dental Manufacturing Co 1, LLC. (006309355)

Establishment
Name	Address	ID/FEI	Operations
Medical Products Laboratories, Inc.		002290302	manufacture (0273-8016)

Revised: 12/2018 Young Dental Manufacturing Co 1, LLC.